Director of Quality

Kelly® Science & Clinical is seeking a Director of Quality, for a direct hire opportunity with one of our clients, a leading global ingredient manufacturer at their Loveland, CO facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Title: Director of Quality

Position Type: Direct Hire

Workplace: Onsite in Loveland, CO

• Salary Range: $120,000 - $160,000
• Inclusive work culture with ongoing industry training, professional development, and opportunities for growth in the cannabinoid sector.

Position Overview

The Director of Quality is a key member of our client’s operations leadership, reporting directly to the Chief Operations Officer. This role oversees all aspects of global quality and compliance, providing vision and direction for regulatory affairs and quality management systems that support both immediate and future organizational needs. The Director is responsible for developing, implementing, and refining scalable quality processes, policies, and procedures, ensuring our quality programs create value for partners and adapt to a dynamic international industry. Below are the foundational responsibilities of this role.

Key Responsibilities

Quality Management Systems

• Lead the implementation, ongoing maintenance, and continuous improvement of the Quality Management System (QMS), ensuring full compliance with applicable regulations for the manufacture, packaging, storage, and distribution of all products.
• Maintain up-to-date product, component, and packaging specifications to support purchasing and manufacturing requirements.
• Oversee document control policies and practices to support GMP compliance.

Quality Function Leadership

• Direct the quality department’s continuous improvement initiatives to enhance quality programs in alignment with both existing and emerging global regulations.
• Manage daily quality operations and build strategic infrastructure for long-term quality goals, optimizing release velocity, batch record efficiency, and testing processes to eliminate production delays and strengthen regulatory positioning.
• Sustain regulatory compliance across all processing and storage facilities, meeting GMP standards and all relevant licensure requirements at local, state, and federal levels.

Global Quality Affairs

• In coordination with external regulatory and legal advisors, lead the development and ongoing management of global quality and compliance strategies addressing diverse regional requirements for product distribution.
• Direct quality and regulatory strategies for Novel Foods (UK/EU), FDA (US), PMDA (Japan), TGA (Australia/New Zealand), and emerging international markets.

Strategic Partner Excellence

• Position the organization as a regulatory intelligence leader in both domestic and international cannabinoid markets.
• Maintain and expand key certifications (GMP, NSF, Kosher, etc.), ensuring readiness for new market opportunities.
• Lead customer audits and compliance reviews that reinforce our competitive advantage.
• Oversee internal and external audits, vendor compliance, and laboratory testing partnerships to guarantee analytical accuracy, swift turnaround, and cost efficiency.

Cross-Functional Leadership & Continuous Improvement

• Optimize quality systems across production and supply chain functions for greater efficiency, scalability, and full regulatory compliance.
• Ensure comprehensive training and proficiency for all personnel in relevant policies, SOPs, and protocols to support GMP requirements and consistent manufacturing practices.
• Lead root cause investigations and leverage continuous improvement tools (CAPA, SPC, DMAIC) to drive systemic enhancements from quality incidents.
• Collaborate with R&D and executive teams to identify and advance scientific and regulatory strategies that align with organizational goals.

Qualifications & Requirements

• Bachelor’s degree in Science, Engineering, or a related technical discipline required; advanced degree preferred.
• Minimum 10 years’ experience leading quality in an FDA-regulated manufacturing environment (pharmaceuticals, dietary supplements, medical devices).
• At least 5 years managing quality teams, including talent selection, development, and performance management.
• Deep expertise in 21 CFR Part 111 (dietary supplements), pharmaceutical GMPs, or equivalent standards.
• Demonstrated experience with regulatory agencies and third-party certification processes.
• Proven track record building and scaling quality systems during periods of significant growth.

Preferred Experience

• International regulatory compliance (Novel Foods, TGA, ANVISA, etc.).
• Prior experience in hemp or cannabinoid production.

What happens next

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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